Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead

RELIANCE 4-FRONT™ Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up (PMCF) Study

The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads.

The RELIANCE 4-FRONT Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up Study is a prospective, non-randomized, multi-center, single-group, post market clinical study to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT passive fixation defibrillation leads.

A total of 167 patients (including 10 % attrition) are required to evaluate the Primary Endpoint.

Up to 10 Investigational centers located in Europe and Israel. Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.

Lead-related complications associated with the RELIANCE 4-FRONT passive fixation lead will count toward this endpoint.

Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.

Lead-related complications associated with the RELIANCE 4-FRONT passive fixation lead will count toward this endpoint.

• Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant
• Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant
• Sensed Amplitude at 3 Months Post-Implant
• Pacing Impedance at 3 Months Post-Implant All endpoints will be assessed for the RELIANCE 4-FRONT passive fixation lead.

Clinic visits will occur at:

• Enrollment Visit (no later than 30 days prior to implant procedure)
• Implant Procedure (Day 0; all future follow ups based on this date)
• Pre-Discharge Clinic Visit (3 - 72 hours post-implant)
• One Month Clinic Visit (30±7 days)
• 3 Month Clinic Visit (91 ± 21 days)
• 6 Month Clinic Visit (180 ± 30 days)
• 12 Month Clinic Visit (365 ± 45 days)
• 18 Month Clinic Visit (545± 45 days)
• 24 Month Clinic Visit (730 ± 45 days) The study will be considered completed after all subjects have completed the 24 Month follow-up and study completion is anticipated in 2015. Primary endpoint completion is anticipated after all subjects have completed the 3 Month follow-up visit. All study required visits will be completed during clinic visits.

Hypotheses testing in the RELIANCE 4-FRONT passive fixation PMCF Study will use standard statistical methodology as specified more in detail in the protocol.

Inclusion Criteria:

• Willing and capable of providing informed consent
• Has an indication for implantation of a single or dual chamber ICD or CRT-D system in their respective geography
• Subjects planned to be implanted with the RELIANCE 4-FRONT Passive Fixation Lead
• Willing and capable of participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
• Age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

• Known or suspected sensitivity to Dexamethasone Acetate (DXA)
• Mechanical tricuspid heart valve
• Subject is enrolled in any other concurrent study without prior written approval from Boston Scientific (BSC), with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:
• Schedule of procedures for the RELIANCE 4-Front Study (i.e. should not cause additional or missed visits);
• RELIANCE 4-Front Study outcome (i.e. involve medications that could affect the heart rate of the subject);
• Conduct of the RELIANCE 4-Front Study per Good Clinical Practice (GCP)/ International Organization for Standardization (ISO) 14155:2011/ 21 CFR 812/ local regulations
• Currently on the active heart transplant list
• Documented life expectancy of less than 12 months
• Women of childbearing potential who are or might be pregnant at the time of study enrollment (method of assessment upon physician discretion)
• Currently requiring chronic dialysis